Ezetimibe/rosuvastatin

Ezetimibe/rosuvastatin
Combination of
Ezetimibe	Hypolipidemic agent
Rosuvastatin	Statin
Clinical data
Trade names	Ridutrin,Cholerose Plus, Lipocomb, Rosuzet, others[1][2]
AHFS/Drugs.com	Multum Consumer Information
License data	US DailyMed: Ezetimibe_and_rosuvastatin;
Pregnancy; category	AU: D[3];
Routes of; administration	By mouth
ATC code	C10BA06 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only) [3]; US: ℞-only [4]; EU: Rx-only [2]; In general: ℞ (Prescription only);
Identifiers
KEGG	D11520;

Ezetimibe/rosuvastatin, sold under the brand name Ridutrin among others, is a combination medication used to treat high cholesterol.[5][6] In some countries it is sold as a kit or a pack containing two distinct pills.[7][1] It is also available in the form of a composite package containing the two separate pills.[3]

The combination was approved for medical use in the United States in March 2021.[4]

Medical uses

Ezetimibe/rosuvastatin is indicated as an adjunct to diet in people with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C); and alone or as an adjunct to other LDL-C-lowering therapies in people with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.[8]

References

"Rosuvastatin international". Drugs.com. 3 February 2020. Retrieved 17 February 2020.
"Ezetimibe/rosuvastatin: List of nationally authorised medicinal products" (PDF). European Medicines Agency (EMA). 21 March 2018. PSUSA/00010271/201707. Retrieved 17 February 2020.
"TGA eBS - Product and Consumer Medicine Information Licence".
"Roszet: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 24 March 2021.
"Ridutrin SmPC" (PDF). Medicines Data Bank. 30 May 2019. Retrieved 17 February 2020.
Willihnganz MJ, Gurevitz SL, Clayton BD (November 2021). "HMG-CoA Reductase Inhibitor Combination Products". Clayton's Basic Pharmacology for Nurses - E-Book. Elsevier Health Sciences. p. 344. ISBN 978-0-323-81258-0.
"Rosuzet Composite Pack". NPS MedicineWise. 8 January 2020. Retrieved 17 February 2020.
Sharretts J (23 March 2021). "NDA Approval Letter for Roszet (rosuvastatin and ezetimibe)" (PDF). Center for Drug Evaluation and Research. U.S. Food and Drug Administration.

External links

"Ridutrin (rosuvastatin zinc/ezetimibe) Public Assessment Report Scientific discussion" (PDF). NL/H/3017/001-003/DC.

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[Drugs.com_international-1] "Rosuvastatin international". Drugs.com. 3 February 2020. Retrieved 17 February 2020.

[EMA_Ezetimibe/rosuvastatin-2] "Ezetimibe/rosuvastatin: List of nationally authorised medicinal products" (PDF). European Medicines Agency (EMA). 21 March 2018. PSUSA/00010271/201707. Retrieved 17 February 2020.

[Rosuzet_composite_pack_PI-3] "TGA eBS - Product and Consumer Medicine Information Licence".

[FDA_Roszet-4] "Roszet: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 24 March 2021.

[5] "Ridutrin SmPC" (PDF). Medicines Data Bank. 30 May 2019. Retrieved 17 February 2020.

[6] Willihnganz MJ, Gurevitz SL, Clayton BD (November 2021). "HMG-CoA Reductase Inhibitor Combination Products". Clayton's Basic Pharmacology for Nurses - E-Book. Elsevier Health Sciences. p. 344. ISBN 978-0-323-81258-0.

[7] "Rosuzet Composite Pack". NPS MedicineWise. 8 January 2020. Retrieved 17 February 2020.

[8] Sharretts J (23 March 2021). "NDA Approval Letter for Roszet (rosuvastatin and ezetimibe)" (PDF). Center for Drug Evaluation and Research. U.S. Food and Drug Administration.